Recently, Human Genome Sciences Inc. (HGSI) announced that the U.S. Food and Drug Administration (FDA) delayed the approval of ABthrax (raxibacumab), the company’s candidate for anthrax treatment, asking for additional information pertaining to the drug.   The agency issued a complete response letter wherein it asked for additional information in response to the Biologics License Application (BLA) filed in May 2009. The company intends to provide the agency with the requested information shortly.   The agency’s decision comes weeks after an FDA advisory panel questioned the drug’s effectiveness when compared to existing anti-bacterial drugs since ABthrax was primarily tested in animals, not humans. Late last month, the panel of experts voted 17 to 6, with one abstention, that the company should submit more evidence on whether adding ABthrax to older drugs is beneficial for anthrax treatment. Consequently, the decision to delay approval does not surprise us.   As ...

This post provides links to a number of interesting articles I have read over the past few days that you may also enjoy.

• Vito Racanelli (Barron’s): The easy money has been made, November 2, 2009. The choppy action last week suggests the going gets much tougher from here. In a year in which the market has jumped far off its lows, the bull has so far talked the talk of earnings growth. It’s time to walk the walk.

• Edward Harrison (Credit Writedowns): Bullish data, recoveries, crashes and the psychology of forecasting redux, November 2, 2009. Is a double dip or crash a baseline scenario? No, not necessarily - but it is increasingly likely. So, as bullish as I believe the data are, I am more worried about a bad outcome, not less.

• Andy Kessler (The Wall Street Journal):

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This post provides links to a number of interesting articles I have read over the past few days that you may also enjoy.

• Vito Racanelli (Barron’s): The easy money has been made, November 2, 2009. The choppy action last week suggests the going gets much tougher from here. In a year in which the market has jumped far off its lows, the bull has so far talked the talk of earnings growth. It’s time to walk the walk.

• Edward Harrison (Credit Writedowns): Bullish data, recoveries, crashes and the psychology of forecasting redux, November 2, 2009. Is a double dip or crash a baseline scenario? No, not necessarily - but it is increasingly likely. So, as bullish as I believe the data are, I am more worried about a bad outcome, not less.

• Andy Kessler (The Wall Street Journal):

...

A panel of experts of the US Food and Drug Administration (FDA) has recently asked for additional data to judge the efficacy of Human Genome Sciences Inc.’s (HGSI) anthrax infection treatment ABthrax (raxibacumab) compared to existing anti-bacterial drugs.  The panel of experts voted 17 to 6, with one abstention, that the company should submit more evidence on whether adding ABthrax to older drugs is beneficial for anthrax treatment.  Data from studies had revealed that antibiotic medicines used alone were highly effective against anthrax, thereby raising questions about the added benefit of ABthrax. Furthermore, the drug appeared to be effective when used with antibiotics in rabbits and monkeys. The same panel also voted in favor of using data from the animal studies to predict how the drug will work in humans. However, more data is required for the purpose. Last week, the FDA expressed concerns regarding some ...

San Francisco, Calif. - October 26, 2009 - Today, Secretary Chu announced the first $151 million in grant funding through the Advanced Research Projects Agency - Energy.

David Einhorn, highly respected hedge fund manager of Greenlight Capital and author of “Fooling some of the people all of the time” yesterday delivered the keynote address at the Value Investing Congress. His full speech can be accessed here, but Rolfe Winkler of Reuters has very handily published the highlights, as posted below.

On Bernanke and Geithner: Presently, Ben Bernanke and Tim Geithner have become the quintessential short-term decision makers. They explicitly “do whatever it takes” to “solve one problem at a time” and deal with the unintended consequences later. It is too soon for history to evaluate their work, because there hasn’t been time for the unintended consequences of the “do whatever it takes” decision-making to materialize.

On too big to fail and the true lesson of Lehman: The proper way to deal with too-big-to-fail, or too inter-connected to fail, is to make sure

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The Economist’s Buttonwood Gathering, a conference bringing together global regulators and bankers to discuss and debate new ideas and develop a new set of guidelines moving forward, has just taken place in New York. Michael Panzer, writer of the Financial Armageddon blog and author of “Financial Armageddon: Protect Your Future from Economic Collapse”, was in attendance and has kindly shared some of the more interesting quotes on his blog, as reported below.

Secretary Tim Geithner, United States Department of the Treasury:

“Generally, we did not do enough.” (Referring to the failure to address growing concerns over excessive risk-taking in the period leading up to the financial crisis.) [Editor's note: understatement of the year?]

Stephen Roach, Chairman, Morgan Stanley Asia:

Those who are looking for a “V”-shaped recovery are in for “a rude awakening.”

“The imbalances going into the crisis were large to begin with.

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After enduring extraordinary shocks in 2008, the U.S. banks entered an exceptional state of turmoil in 2009. Starting as a credit issue in the subprime segment of the mortgage market, the sticky situation spread to almost the entire financial services industry, and all corners of the globe. In other words, the financial crisis ultimately morphed into a massive economic crisis, which has had major ramifications across the whole world. Although the banking industry is dealing with liquidity and confidence challenges, it now has financial support from the U.S. government. The government has taken several steps, including programs offering capital injections and debt guarantees, to stabilize the financial system. We believe that the worst of the credit crisis is now probably behind us. After almost a year of initiating the $700 billion Troubled Asset Relief Program (TARP), a lot has improved with respect to the economic crisis, but ...

U.S. stocks ended modestly higher Friday, wounding up a week of solid gains as investors braced for the third-quarter financial results.  Sentiments also got a boost after Federal Reserve Chairman Ben Bernanke indicated that the central bank will be ready to tighten monetary policy once the economy improves.  Bernanke’s tightening comments helped the dollar regain some lost ground.  Bond prices fell sharply. 

After a two-week selloff, fueled in part by concerns that the seven-month old rally had gotten ahead of any economic recovery, stocks got a boost last week following better-than-estimated economic numbers and Alcoa’s (NYSE:AA) surprise quarterly profit.  That helped investors set aside worries and extend the rally.  Meanwhile, White House economic adviser Lawrence Summers reiterated the Obama administration’s commitment to a strong dollar, citing recent comments by U.S. Treasury Secretary Timothy Geithner.

This morning’s stock futures show markets are headed for a higher opening as the busy

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BioCryst Pharmaceuticals have clarified today that the Government Declaration about their antiviral Peramivir requires a step before they can issue an Emergency Use Authorization or EUA.  The company announced that the Office of the Secretary, Department of Health and Human Services (HHS) has issued “HHS Secretary’s Declaration for the Use of the Public Readiness and Emergency Preparedness Act for the Influenza Antiviral Peramivir”. The Notice of this Declaration was posted in the Federal Register and is also available on the web site of the Federal Register. U.S. Centers for Disease Control (CDC) has provided more information about the new EUA policies in their review which one can also look up on their web site.

BioCryst Pharmaceuticals normally designs, optimizes and develops small-molecule pharmaceuticals that block key enzymes involved in infectious diseases

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